Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring

Issued by:

Guidance Issuing Office

Office of Regulatory Affairs

Office of Good Clinical Practice

Center for Drug Evaluation and Research

Center for Devices and Radiological Health

Center for Biologics Evaluation and Research

This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting.